BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    IDx-DR

    K Number: DEN180001 · Decision Apr 11, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    IDx-DR
    K Number
    DEN180001
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    886.1100
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Idx, LLC
    Date Received
    January 12, 2018
    Decision Date
    April 11, 2018
    Product Code
    PIB
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PIB Diabetic Retinopathy Detection Device

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